JP2002535091A - Impeller blood pump with port sealed in retracted position. - Google Patents

Abstract

The present invention is a blood pump (20) including an outer sleeve (32), an inner sleeve (38), and a pump mechanism (24) having an impeller. The pump mechanism (24) is sealed by one or both of the suction ports (34) and the discharge port by inner and / or outer sleeves (38, 32) for inserting the pump mechanism (24) into the heart. Closed, preferably contracted, and said inlet and outlet (34,48) are open, preferably open to allow the impeller to pump blood through said port, It is movable in an extended state (shown). The pump mechanism (24) is preferably not long and is easier to operate more quickly when in the closed state. Also disclosed is a bearing in the cap of the impeller with a smooth liquid flow in the bearing, a cap and a method of using the pump (20).

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an intravascular blood pump, and more particularly to a pump adapted to be inserted into the apex of the heart or to the heart via the aorta.

[0002]

[Prior art]

In recent years, significant progress has been made in the field of cardiac surgery. Surgical procedures that treat the heart, or the blood supply of the heart, are often performed today. One of the best known is a procedure called coronary artery bypass grafting. This procedure is used to replace blood vessels that have been resected from other parts of the patient's body with parts of the aorta that have been damaged by the disease. During such procedures, it is necessary to pump the blood and pass it through any bypass where oxygen is pumped out, or to temporarily take over the function of the heart by using an intravascular blood pump. is there.

[0003] Intravascular blood pumps are known to have a drive section integral with them, examples of which are disclosed in US Pat. Nos. 5,147,388 and 5,275,
No. 580. Other examples are contemplated by powering from a remote power source, for example, via a drive shaft or drive cable, examples of which are described in U.S. Patent Nos. 4,625,712, 4,846,152, 4,964,864, And 5,112,349.

[0004] For example, it is known to insert an intravascular pump into the heart from a femoral artery or aorta through a vascular network. This is described, for example, in US Pat. No. 4,625,71.
No. 2,846,152, and 4,944,722. This alternative device has the disadvantage that the aortic valve of the heart must be inserted "backward", i.e. against the direction of natural flow. Thus, great care must be taken to avoid damage to the thin skin flap of the tissue forming the valve.

It is known to pierce the heart wall at the apex of the heart and insert a blood pump in a blood vessel directly into the heart. For example, U.S. Patent Nos. 5,147,388, 5,2
See U.S. Patent Nos. 75,580, 5,376,114, 5,755,784, and 5,776,190.

[0006]

[Problems to be solved by the invention]

There are two problems with the use of intravascular blood pumps inserted from these apex. That is, first, such devices tend to be long and stiff, making it difficult to direct the pump into position relative to the internal structure of the heart. Second, the heart is usually under pressure, so that during insertion of the pump when the pump outlet is inside the heart and the pump inlet is still outside the heart, the blood Often, there is a tendency for pressure to be applied later through the pump, so as to squirt into the opening.

[0007] It is also relevant to the approach to the left atrium. This approach involves making an incision at the top of the heart into the left atrium and penetrating the pump through the mitral valve to locations on both sides of the heart valve. Alternatively, this approach involves penetrating the pump through the pulmonary vein into the left atrium.

[0008]

[Means for Solving the Problems]

The present invention provides a blood pump having an inlet port and an outlet port, wherein at least one port is adapted to fluid flow such that the blood pump can be inserted into the heart with the port closed. The port can be opened and closed, after which the port can be opened to allow pumping of blood. For example, if the pump is inserted through the apex of the heart, the closed port will limit blood loss or ejection of blood through the suction port while the blood pump is inserted into place, or Hinder.

In one aspect of the invention, an intravascular blood pump typically includes a drive and a pump mechanism. The pump mechanism has an inner sleeve and an outer sleeve slidably engaged with each other, and an impeller mounted in at least one of the inner and outer sleeves. One of the inner sleeve and the outer sleeve has a port, and the other is movable with respect to the port between a first state of sealing the port and a second state of opening the port. is there. The impeller is operatively connected to a drive that rotates the impeller to pump fluid through the port.

Preferably, the pump mechanism of the blood pump has two parts that move relatively axially after the pump mechanism is inserted through the apex of the heart. Thus, the blood pump can be moved into position while being short, ie, easily operated. For example, the blood pump may be positioned near the aortic valve in a short period of time. And, once located, the outlet of the pump mechanism extends forward and opens as one part slides forward relative to the other, and the inlet sealed during insertion is Open as well.

[0011] Alternatively, for example, the suction and / or discharge ports may rotate one part relative to the other and be opened and closed by rotation.

The present invention is conceived as an intravascular blood pump having a cable member and a pump mechanism attached to the cable member. The cable member has an outer sheath, an inner sheath partially enclosed by the outer sheath, and a drive cable partially enclosed by the inner sheath. The pump mechanism has an outer sleeve, an inner sleeve, and an impeller. The inner sleeve has an outlet that allows patient blood to enter the pump mechanism and is attached to the outer sheath of the cable component. The inner sleeve slidably engages the outer sleeve and is attached to the inner sheath of the cable member. The impeller is provided in the inner sleeve and is attached to the drive cable. The pump mechanism assembled in this manner is movable between a retracted state, in which the port is sealed by the inner sleeve, and an open state, in which the port is filled with blood into the impeller.

[0013] In a preferred embodiment, after the intravascular blood pump is surgically inserted, it is attached to the inner sheath such that the pump mechanism can be locked in an extended state while present in the patient. And a locking mechanism is provided that is adapted to engage the outer sheath. Advantageously, the connection between the inner sheath and the inner sleeve is achieved by a support member. Also advantageously, a tip member is mounted at the tip of the impeller for supplying the protective tip and at a location close to the inner sleeve, improving blood flow characteristics in this region.

[0014] The intravascular blood pump according to the invention is particularly adapted for tip insertion, and if the impeller is inverted, the invention can be used for insertion from the aortic valve into the heart. it is obvious. Many of the desirable characteristics of the pump have already been provided to the physician in such a mode.

[0015] In another aspect of the invention, an intravascular blood pump generally includes a flange, a sheath with an inner lumen, and a drive cable partially surrounded by the inner lumen. The sheath generally has a bearing adjacent the flange. The bearing has an end, at least one slot extending substantially between the flange and the end, and a channel along an end of the bearing that provides fluid communication between the inner lumen and the slot. The impeller is provided on the drive cable such that the impeller rotates when the drive cable rotates. The impeller has a cap that receives the bearing portion of the sheath. The cap slidably engages the end of the bearing for rotation with respect to the bearing. The cap has a flange positioned adjacent but not in contact with the sheath flange to form a gap that allows fluid to escape from the fluid layer between the cap and the bearing. Means for reversing such fluids are provided to direct the fluid flow to the lumen of the sheath such that the fluid flow passes through a slot for forming a fluid layer between the cap and the bearing. You.

Most preferably, the bearing portion includes a plurality of longitudinally extending slots substantially equally spaced along the bearing portion and fluid communication between the inner lumen and the plurality of slots. And a plurality of channels fed along the end of the bearing.

In yet another aspect of the invention, an intravascular blood pump generally has a pump housing having a central axis, and an inlet and an outlet defining upstream and downstream directions. A suction flow rectifier is provided with the housing downstream of the suction port to regulate blood entering the pump housing with the central axis through the suction port.

An impeller is provided in the housing downstream of the rectifier for the suction flow and is provided for rotation for pumping blood from the suction port to the discharge port. A discharge flow rectifier is provided in the housing downstream of the impeller. The outlet rectifier has wings extending substantially from the impeller to approximately the outlet, the wings being relatively relatively centered with respect to the central axis so as to reduce the circumferential configuration of the blood flow velocity before the blood discharges. It is curved from the radial direction to the axial direction relatively to the central axis.

Preferably, the pump housing is generally cylindrical, the outlet generally extends circumferentially around the pump housing, and the pump housing is generally radially outward of the blood through the outlet. To form a conical or frusto-conical structure adjacent to the orifice that is opened to rapidly promote the flow of water. Also preferably, the inlet has a plurality of inlets radially spaced along the pump housing. This allows the heart wall to avoid blocking the inlet if the inlet is brought closer to the heart wall.

Conveniently, the drive cable is operatively connected to the impeller to rotate the impeller, and the rectifier of the suction flow has a passage extending such that the drive cable is operatively connected to the impeller.

The above description and other features are set forth below.

The present invention is further extended with reference to the drawings, wherein corresponding reference features depict corresponding parts throughout the several views of the drawings.

[0023]

BEST MODE FOR CARRYING OUT THE INVENTION

Referring to FIG. 1, a side view of an intravascular blood pump 20 is shown in an extended state. The intravascular blood pump 20 has a cable component 22 and a pump mechanism 24. The cable component 22 has an outer sheath 26, an inner sheath 28 partially surrounded by the outer sheath, and a drive cable 30 partially surrounded by the inner sheath. The pump mechanism 24 has an outer sleeve 32 having an outer sleeve wall 33 with a first or proximal port 34 (preferably a suction port). The outer sleeve 32 is attached to the outer sheath 26 of the cable component 22, preferably by a hub 36 having a smooth surface that facilitates removal of the pump mechanism 24 from the patient's vasculature. Has been achieved.

The pump mechanism 24 also has an inner sleeve 38 slidably engaged with the outer sleeve 32. The inner sleeve 38 has an inner sleeve wall 40
And preferably terminates in a tip member 42 attached to the inner sleeve wall 40. The tip member 42 preferably has wings 44 to facilitate the desired flow pattern for outward flowing blood and smooth surfaces to facilitate insertion of the pump mechanism 24 into the patient's vasculature. And a chip portion 46. The wings 44 preferably include wings that are curved from a direction extending substantially radially outward from near the impeller to a direction substantially axially adjacent to the downstream edge of the outlet.

Preferably, the tip portion 46 comprises a dilator tip that is inserted through a small hole in the tissue of the heart. For example,
The tip portion 46 generally has a conical and / or inclined configuration to facilitate insertion. The extended tip 46 may be formed of metal (such as stainless steel), plastic, or a standard compliant elastomer.
In particular, in the case of an elastomeric tip 46, an insertion and retention plug (not shown) is provided to extend the tip 46 to a predetermined location within the pump (eg, to retain it on the wing 44). It is conceivable that the tip portion 46 can be extended in the axial direction. Further, the tip wing portion 44 and the extending tip portion 46 are formed integrally, for example, by molding, opposite to the two components attached to each other.

The pump mechanism 24 has a distal end port 48 provided near the distal end member 42 when extended, as shown in FIGS. 1, 3, 5 (a) and 7. Have. In other words, to express this differently, when the pump mechanism 24 is extended, the second or tip port 48 is open. This second port 48 is preferably a discharge port.

The first or proximal port 34 preferably has a plurality of radially spaced openings or slots (34) along the outer sleeve 32. This preferably opening slit 34 preferably extends in the axial direction, ie in the longitudinal direction. This preferred arrangement having a plurality of openings spaced from one another provides a suction port 3
This is particularly desirable for use as an inhalation port 34, as it will prevent the port 34 from closing if it hits the heart wall. The second port 48 preferably extends completely circumferentially near the distal end of the inner sleeve 38 and forms an annular opening (48) between the distal tip 42 and the inner sleeve 38. As inner sleeve 38 is advanced distally relative to outer sleeve 32, inner sleeve 38 does not occlude proximal port 34, and outer sleeve 32 does not cover distal port 48.

A locking mechanism 50 is attached to the inner sheath 28 and is provided to engage the outer sheath 26 to lock the pump mechanism 24 when extended during use. For example, the locking mechanism 50 can be formed by an inter-threaded connection that can be rotated to lock the pump mechanism 24 when in the extended state. Further, as other lock mechanisms, for example, a spring arm type lock mechanism, an over center lock mechanism, a bayonet type lock mechanism, and the like may be employed. In the case of a pump mechanism that opens and closes at least one port by axially moving the other sleeve relative to one sleeve, a suitable locking mechanism that prevents axial movement, ie, translation, may be employed. .

As used herein, the terms “proximal” and “distal,” or similar terms, are used to refer to the axially opposite directions of the pump 20.

The distal member 42 defines the distal end of the pump 20, and the opposite direction of the pump 20 is the proximal direction.

As used herein, the terms “suction port” and “discharge port” are intended to be used as inlets or outlets in special uses of the pump.

The first port 34 is a relatively proximally located port, and in a preferred embodiment, is a suction port. This arrangement is used when the pump is inserted into the patient's heart via the apex of the heart. In different designs, the relatively proximally located port is the discharge port, as this different design relates to pumping the heart from other directions, for example through the aorta. "Tip port", "
The term “proximal port”, “first port”, or “second port” is used when its meaning is not limited to the suction port or the discharge port.

As used herein, “to” is used in connection with the movement of one part relative to the other, for example, when a fixed part moves relative to a movable part. Yes, it means that one actually moves with respect to the other part. As used herein, "one"("a","an", and "the"
")" Is a "single"("asingle" or "the single"
e)) does not include a plurality while the term does not include a plurality.

The terms “downstream” and “upstream” are defined for the intended flow of blood from the inlet to the outlet. The term “central axis” with respect to the pump housing (ie, inner and outer sleeves, tips, etc.) means the axis defined by the generally cylindrical inner and outer sleeves.

Referring to FIG. 2, the intravascular blood pump 20 of FIG. 1 can be seen in a collapsed state in a side view. Outer sheath 26 has been moved relative to inner sheath 28 in the direction of arrow 52. The second port 48 is approached so that the tip member 42 is pulled out of the end of the inner sleeve 40 and the first port 34 is also approached and locked by the surface of the inner sleeve wall 40. .

Although longitudinal movement between the sleeves is considered favorable for opening the port and aligning the pump for use after insertion, these objectives are instead achieved by rotational movement. It will be appreciated that an intravascular blood pump 24 may be constructed to obtain. For example, the pump may be designed such that the first port and the second port can be opened and closed by relatively rotating the sleeve. In general, these inner and outer sheaths can be said to be a preferred embodiment of control over the two sleeves, which allows them to be conveniently operated.

Referring to FIG. 3, the blood pump in the blood vessel of FIG. 1 is again seen in an extended state, but now in partial cross-section. In this view, the outer sleeve 32 having a support member 54 attached to the inner sheath 28 can be seen. In addition, to provide structural functionality, the support member 54 has wings 55 that rectify a better hydrodynamic flow of blood through the pump mechanism 24. The impeller 56 is provided on the inner sleeve 38 and is attached to the drive cable 30.

Referring to FIG. 4A, a cross-sectional view of a human heart 60 is shown. In this figure, an intravascular blood pump has been inserted into the apex 62 of the heart to assist or replace the normal pumping function of the left atrium 64. To accomplish this, the intravascular blood pump 20 must pump blood from the left atrium 64 through the aortic valve 66 to the upstream aorta. In the movement shown in FIG. 4 (a), the second port 48 of the intravascular blood pump 20 is in the left atrium 64 and the first port 34 is outside the heart 60. As the blood pump in the vessel is inserted in a contracted condition, the first port 34 and the second port 48 are closed to close off the backflow of blood through the pump. As provided by the present invention, during insertion, if there is no closed one or both port characteristics, the left atrium 64
Due to the fundamental pressure therein, blood flows back through the pump back to the surgical site.

Referring to FIG. 4B, the insertion is continued, and the blood pump 20 in the blood vessel is moved to a predetermined position. Another advantage of a preferred embodiment of the present invention is that
Can be understood. In FIG. 4 (b), the blood pump 20 in the blood vessel is not being sent in the proper direction and must be withdrawn slightly in the opposite direction to re-direct in the correct direction. Because of the short length of the pump mechanism 24, it is relatively easy to operate at close range within the heart 60 when in the contracted state.

Referring to FIG. 5 (a), the blood pump 20 in the blood vessel is located at an appropriate place for operation and is in an extended state. When most desired, the first port 34 and the second port 48 are open on either side of the aortic valve 66.

Referring to FIG. 5B, the intravascular blood pump 20 is shown as being removed from the heart. The smooth wall of the hub 36 facilitates removal of the pump mechanism 24. In turn, the pump mechanism 24 may be connected to the first port 3 so as to prevent or at least limit blood leakage through the pump mechanism 24.
It is in a contracted state to seal the fourth and second ports 48.

Referring to FIG. 6, a side view of a different embodiment of the intravascular blood pump 20 is shown. It is often useful to guide a fluid material, such as a heparinized salt, which reduces thrombogenic properties, through the pump mechanism 24, or to remove a fluid material, such as a blood sample for analysis, through the pump mechanism. In that respect, the different embodiments shown have optional passageways for these purposes. Fluid connectors 70, 71 connect tubes 72, 73 to a syringe,
It has an auxiliary device for connecting to a drip bag or a sample collection container, respectively.

In FIG. 7, internal passages 74, connected to tubes 72, 73, respectively,
75 is connected inside the wall of the outer sheath 26 to guide fluid toward or away from the pump mechanism 24 during use of the intravascular blood pump 20.

In one embodiment, an inflatable balloon 7 that can be deflated for insertion
6 is conveniently supplied and the pump mechanism 24 is inflated while using the fluid connector 77, the tubing 78, and the passage 79 in the heart. At that time, the cable component 22 may be withdrawn slightly, pulling the balloon 76 into contact with the inner wall of the heart and reversing the surgical cut to reduce any leakage of blood.

Referring to FIG. 8, a detailed cross-sectional view of a portion of the pump mechanism 24 is shown to illustrate a preferred embodiment of the connection and support mechanisms. The inner sheath 28 is conveniently connected to a spindle 82 by a screw or barbed section 84. Flange 86 properly captures support member 54. Gap 88 is attached to impeller 56 and is intended to rest on and rotate around support 90 of spindle 82. The drive cable 30 is conveniently attached to the upper end 92 of the cap 88, for example, by welding, soldering, or adhesive. At its lower end, the cap 88
It has its own flange 94, the part being dimensioned and assembled such that there is a gap 96 between the flange 86 of the spindle 82 and the flange 94 of the cap 88. This gap 96
A width of about 0.005 to 0.010 inches (0.125 to 0.250 mm) may be desirable.

Gap 96 provides a hydrodynamic bearing system. Referring to FIG. 9, a detailed perspective view of the bearing portion 90 of the spindle 82 is shown. One or more slots 98, conveniently four, are rolled out of the bearing portion 90, each slot 98 being formed with an end adjacent to the channel 100. Each channel 100 extends radially outward from an inner lumen to a slot 98 along a tip 102 of a bearing portion 90 of a spindle 82. This tip 102 supplies the impeller with a thrust bearing surface. Most preferably, the slots 98 extend longitudinally along the bearing portion 90 and are equally spaced such that, for example, the four slots 98 are substantially equally spaced at 90 degree intervals.

In a preferred embodiment, the flow of liquid, conveniently saline, is directed under low pressure to the lumen of the inner sheath 28. And this flow is channel 1
It flows out of inner sheath 28 through slot 00 and into slot 98. The fluid flow rate is such that the cap 88 rides on a thin layer of fluid between the cap and the bearing 90.
Adapted. For example, the fluid flow rate can be adapted with a conventional roller clamp (not shown) of the type used in IV lines, and the fluid can be supplied by a flexible reservoir or a bag of saline. This fluid flows out through gap 96 and is pumped by impeller 56 and diluted into the bloodstream.

Considering that a radially extending channel 100 is initially preferred, for example,
The skilled worker will find that there are other mechanical ad-hoc methods to allow the required flow of fluid so that a small hole is drilled in the slot 98 connected to the inner lumen of the bearing 90. There will be.

FIG. 10 shows an exploded view of the main flow operating components of the pump mechanism 24 as described above, ie, the support member 54, the impeller 56, and the tip wing 44. . FIG. 10 (a) can be contrasted with FIG. 10 (b), which is a different embodiment where the pump mechanism is adapted for insertion from the aortic valve into the heart. In FIG. 10A, the wings 55 on the support member 54 are adapted to rectify the flow at the end of the inlet of the impeller 56. At the end of the outlet of the impeller 56, the wings 44 of the tip are adapted to diffuse the blood flow and reduce angular momentum with little damage to the cells of the blood. Symmetrically, FIG. 10 (b) shows that the wing 44a of the tip member has the impeller 56 acting in reverse.
a adapted to straighten the flow at the end of the inlet of a. At the opposite end of the outlet of the working impeller 56a, the wings 55a of the different support members 54a are adapted to diffuse the blood flow.

US Pat. Nos. 5,354,288, 5,616,137 and 5,6
No. 85,865 discloses various low speed or fluid diffusion catheters, of which the preferred embodiment of the outlet and the wing near the outlet is incorporated by reference. .

Outer sleeve wall 33 and inner sleeve wall 40 are conveniently constructed from thin stainless steel tubing, and a thickness of 0.005 inches (0.125 mm) may be suitable. Conveniently, the intravascular blood pump 20 will be joined in several ways to rotate the drive cable. The skilled person will feel that there are numerous devices available to rotate and install the drive cable. That is, electric and gas motors are considered to be particularly suitable. Also, for example, Sulzur of Winterer
Winterhur, Switzerland, Calnetix, Torrance, California (URL: http: // www.
w. calnetix. com) or RMB-Mekos (RMB-
Mecos), Groton, Connecticut (URL: http
p: // www. rmb-ch. com / GUI / GB_1. html), linear motor drives, such as those of the type commercially available from html), are properly considered.

This type of magnetic drive unit is capable of controlling both the axial direction and the rotation of the drive cable, since there is almost no need for the drive magnet fixed to the drive cable to be inserted into the drive magnetic component. And they are more preferred because they can be easier to use. Further, if the pump is used in the context of an aortic insertion,
Axial control of the cable is particularly desirable, as the impeller tends to move distally to push blood toward the base. Axial control of the cable is used to resist this force.

A drive speed of between about 10,000 and 25,000 revolutions per minute is considered appropriate for moving between about 2 and 4 liters of blood per minute. About 60 to 1
A pressure head between 00 mmHg should be maintained.

In that it is desirable that the sheath be anti-twist to penetrate the vasculature,
Preferably, these components are constructed from a flexible polymer material. Nylon facing lumen and polyurethane facing exterior, 0.050 inch (1.27)
Co-extrusion of nylon / polyurethane with an inner diameter of 0.2 mm) is currently considered more preferred. Multi-bundle stainless steel cables are considered preferred for use as drive cables. In particular, a wrapped multi-bundle cable comprising three bundles spirally wrapped together in one direction to form a core and 4 to 6 bundles helically wrapped in both directions to form a jacket Is currently considered to be preferred, and the composite component is about 0.0
It has a diameter of 40 inches (1.0 mm). Such a structure is available from Suner Manner, Inc. of Rome, Georgia, USA.
ufacturing, ink. ).

The outer windings of the cable bundle may form an Archimedes screw type and serve to pump saline along the cable. This feature is used to pump saline along the cable, preferably in the distal direction or, if the winding direction is opposite to the direction of rotation of the cable, instead in the proximal direction of the cable. Have been. In one preferred embodiment, the cable is coated with a plastic (such as, for example, polyimide) to reduce or limit this pumping function and function, absorb vibrations, or suppress debris. It is understood that such a coating also facilitates the preparation of the cable member.

Also preferably, the length of the cable can be adapted, the cable having a coupling along the length that allows the drive magnet to be changed without removing the pump from the patient's heart. The coupler provides a mechanism for changing the length by making a more precise fit, such as by means of sutures, and by allowing sections of the intermediate cable to be supplied with a sufficient increase in length. can do.

Various techniques may be employed to prepare the pump before use. For example, the pump may be primed with saline before inserting it into the heart. In addition, saline is flowed through the cable / sheath member to drive air from the member. Alternatively, the aspirator may be pumped to draw blood to the pump.

A fiber optic Doppler flow sensor can also be employed in connection with this pump. U.S. Pat. Nos. 4,690,002; 4,989,609;
No., 993,418 discloses various features of a Doppler flow measurement system and is incorporated herein by reference.

A septum or plug can be sutured to the apex of the heart. For example, it is generally contemplated that a self-sealing, pre-filled slit septum, or plug may be sutured at the apex, which provides a type of port to the heart.

It is further contemplated that the pump may be used with a guide wire to facilitate advancing the pump to a predetermined position. For example, a removable guidewire
It can pass through the pump housing between the distal tip and the distal end of the cable sheath. Such a guidewire can be offset from the central axis so as to pass between the wings of the discharge flow rectifier, the impeller, and the rectifier of the suction flow.

Also contemplated is the use of one or two inflatable balloons to seal the heart wall near the incision through the apex of the heart.

One inflatable balloon may be supplied to seal the inside of the heart wall and hold the blood pump away from the heart wall. Preferably, the second inflatable balloon also employs sealing against the outside of the heart wall.

Another conceivable embodiment is to provide an expandable suction basket on the inner sleeve so that the suction basket expands when the outer sleeve is extended distally. This inhalation basket ensures that the heart tissue is well separated from the inlet.

Further, embodiments designed for insertion through the aorta may also have a simple bearing that connects the impeller to the bearing. Such simple bearings have an annular channel and mating threads that help resist centrifugal movement of the impeller relative to the bearing, regardless of the centrifugal force of the blood pumped proximally by the impeller.

As set forth in the claims, various changes can be made in the above structures and means without departing from the spirit of the present invention, and all problems involved in the above description and illustrations in the drawings are presented. And is not meant to be limiting.

[Brief description of the drawings]

FIG. 1 is a side view of an intravascular blood pump according to the present invention in an extended state.

FIG. 2 is a side view of the intravascular blood pump according to the present invention in a contracted state.

FIG. 3 is a partial cross-sectional side view of a blood pump in a blood vessel in the extended state of FIG. 1;

FIG. 4 (a) is a cross-sectional side view of a human heart such that the intravascular blood pump according to FIG. 1 is inserted into the apex. 4B is a view similar to FIG. 4A, except that the blood pump in the blood vessel is in a position to be operated.

FIG. 5 (a) is similar to FIG. 4 (a), except that the intravascular blood pump is positioned in an extended position at a suitable location for the procedure. FIG. (B) is a view similar to (a) of FIG. 4, except that the blood pump in the blood vessel is pulled out.

FIG. 6 is a side view of a different embodiment of an intravascular blood pump having an optional passageway for guiding fluids toward and away from the pump mechanism during use.

FIG. 7 is a cross-sectional view taken along section 7-7 in FIG. 6;

FIG. 8 is a detailed cross-sectional view of a portion of the pump mechanism to show a preferred embodiment of the connection mechanism and the support mechanism.

FIG. 9 is a detailed perspective view of a support portion of the spindle.

FIG. 10 is an exploded view of the main fluid for operating the configuration of the pump mechanism, and (a)
Represents a standard configuration adapted for tip insertion, and (b) is a different embodiment adapted for insertion into the heart via a heart valve.

──────────────────────────────────────────────────続 き Continuation of front page (81) Designated country EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, IT, LU, MC, NL, PT, SE ), OA (BF, BJ, CF, CG, CI, CM, GA, GN, GW, ML, MR, NE, SN, TD, TG), AP (GH, GM, KE, LS, MW, SD, SL, SZ, TZ, UG, ZW), EA (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), AE, AL, AM, AT, AU, AZ, BA, BB, BG, BR, BY, CA, CH, CN, CR, CU, CZ, DE, DK, DM, EE, ES, FI, GB, GD, GE, GH, GM, HR, HU, ID , IL, IN, IS, JP, KE, KG, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV, MA, MD, MG, MK, MN, MW, MX, NO, (72) Invention NZ, PL, PT, RO, RU, SD, SE, SG, SI, SK, SL, TJ, TM, TR, TT, TZ, UA, UG, UZ, VN, YU, ZA, ZW Gonzales, Bernard A. USA 55133-3427 St. Paul, P.O.Box 33427 (72) Inventor Castro, Gustavo H.M. F term (reference) 4C077 AA04 AA11 DD09 EE01 FF04

Claims (34)

[Claims] A cable component having an outer sheath, an inner sheath partially surrounded by the outer sheath, and a drive cable partially surrounded by the inner sheath; An outer sleeve attached to the outer sleeve, an inner sleeve slidably engaged with the outer sleeve and attached to the inner sheath, and at least one of the inner sleeve and the outer sleeve. A pump mechanism having an impeller attached to the drive cable, wherein the inner sleeve and the outer sleeve are in a contracted state in which the port is sealed by the inner sleeve; Is relatively movable between an open and extended state to allow fluid transmission to the impeller through the , The blood pump of the blood vessel. 2. A locking mechanism attached to one of the inner sheath and the outer sheath and adapted to engage the other sheath to lock the pump mechanism in the extended state. The intravascular blood pump according to claim 1, further comprising: 3. The inner sleeve further comprises: a support member attached to the inner sheath at a base of the impeller; and a tip member provided at a tip of the impeller and near the impeller. An intravascular blood pump according to claim 1. 4. The port comprises a first port, and the pump mechanism further comprises a second port provided near the tip member;
4. The intravascular blood pump of claim 3 wherein the port is opened when the pump mechanism is extended and closed by the outer sleeve when the pump mechanism is retracted. 5. The inner sheath is attached to a support member by a spindle, the spindle having an inner lumen, a flange and a bearing, the bearing having at least one slot, And at least one fluid connection between the impeller and the slot, the impeller having a cap attached to the drive cable, the cap comprising a flange disposed near a flange of the spindle; Means for directing fluid flow into the inner sheath such that fluid flow passes through the slot to form a fluid layer between the cap and the bearing portion of the spindle. Item 4. An intravascular blood pump according to item 3. 6. The intravascular blood pump according to claim 5, wherein the fluid connection between the inner lumen and the slot is a reduced portion provided near a tip of the bearing. 7. The blood of claim 1, further comprising an inflatable balloon mounted on the outer sheath near the pump mechanism, and means for inflating the balloon. pump. 8. A cable component comprising: (a) an outer sheath, an inner sheath partially surrounded by the outer sheath, and a drive cable partially surrounded by the inner sheath; and a first port. An outer sleeve attached to the outer sheath, an inner sleeve slidably engaged with the outer sleeve, attached to the inner sheath, and disposed distally with respect to the first port. An inner sleeve at least partially forming a second port formed therein; and an impeller provided in the inner sleeve and attached to the drive cable, wherein the first port and the second port are A retracted state wherein at least one is sealed by one of the inner sleeve and the outer sleeve, and wherein the first port and the second port are configured to communicate fluid to the impeller. Providing an intravascular blood pump having a pump mechanism movable between an extended state that is opened to allow access to the heart, and (b) making an incision at the apex of the heart. And (c) maintaining the blood pump in the blood vessel through the cut while maintaining the blood pump in a contracted state so as to approach at least one of the first port and the second port. (D) placing the blood pump in the blood vessel in an extended position, such that the second port is on the opposite side of the heart valve with respect to the first port, and a portion of the inner sleeve. Passing the blood through one of the heart valves; and (e) rotating the drive cable to rotate the impeller to circulate the blood. Provide How to. 9. The method of claim 8, further comprising the step of locking the pump mechanism in an extended state. 10. When the pump mechanism is in a retracted state, the first
9. The method of claim 8, wherein both the port and the second port are closed. 11. The blood pump in the blood vessel further comprises an inflatable balloon mounted on the outer sheath provided near the pump mechanism, wherein the blood pump in the blood vessel is in a deflated balloon. And further comprising the steps of: inflating the balloon after insertion of the blood pump in the blood vessel, inserted through the incision; and pulling back the cable component to bring the balloon into sufficient contact with the inner wall of the heart. 9. The method of claim 8, wherein the method comprises: 12. A drive, one of which comprises a port, the other being movable relative to the port between a first state sealing the port and a second state in which the port is open. An inner sleeve and an outer sleeve slidably engaged with each other, and an impeller provided in at least one of the inner sleeve and the outer sleeve for discharging fluid through the port. A pump mechanism having an impeller operatively connected to the drive to rotate the impeller. 13. The apparatus of claim 12, further comprising a control operably connected to move the inner sleeve and the outer sleeve between the first state and the second state. Intravascular blood pump. 14. The blood pump according to claim 13, wherein the driving unit has the driving cable, and the control unit has at least one sheath surrounding the driving cable. 15. The control device according to claim 15, wherein the sheath is an inner sheath,
15. The intravascular blood pump of claim 14, further comprising an outer sheath such that the inner sheath is partially enclosed within the outer sheath. 16. A locking mechanism attached to one of the outer sheath or the inner sheath and adapted to engage the other sheath to lock the pump mechanism in a second state. 16. The method according to claim 15, further comprising:
An intravascular blood pump according to claim 1. 17. The inner sleeve further includes: a support member provided on a proximal end side of the impeller, to which an inner sheath is attached; and a tip member provided near the impeller on a distal end side of the impeller. 17. The intravascular blood pump of claim 16, comprising: 18. The port comprises a first port, the pump mechanism is opened when the pump mechanism is in a second state, and the first
18. The intravascular blood pump according to claim 17, further comprising a second port provided near the tip member to be closed when in the above state. 19. The inner sheath is attached to the support member by a spindle, the spindle having an inner lumen, a flange and a bearing, the bearing having at least one slot, Providing at least one fluid connection between the lumen and the slot, the impeller having a cap attached to the drive cable, the cap being disposed near a flange of the spindle; Means for guiding the fluid flow to the inner sheath such that the fluid flow passes through the slot to form a fluid layer between the cap and the bearing portion of the spindle, the flange having a flange. 18. The intravascular blood pump according to claim 17, further comprising: 20. The blood pump according to claim 19, wherein the fluid connection between the inner lumen and the slot is a reduction provided near the tip of the bearing. 21. The blood of claim 12, further comprising an inflatable balloon mounted on the outer sheath near the pump mechanism, and means for inflating the balloon. pump. 22. An outer sheath, an inner sheath partially surrounded by the outer sheath, and a drive partially surrounded by the inner sheath, adapted to be inserted into the heart via the apex of the heart. A cable component comprising: a cable; an inner sleeve operatively connected to the inner sheath; a tip member operatively connected to the inner sleeve and / or the inner sheath; and a suction port; The outer sheath is axially moved relative to the inner sheath when the suction port is sealed by the inner sleeve and the outer sleeve seals and engages the tip member. State, wherein the suction port is not sealed by the inner sleeve and the outer sleeve is between the tip member and the outer sleeve. An outer sleeve operatively connected to the outer sleeve to move the outer sleeve axially relative to the inner sleeve, between an open state spaced from the tip member forming an inlet at A pump mechanism having at least one of the inner sleeve and the outer sleeve, the impeller being operably connected to the drive cable such that the impeller is rotated when the drive cable rotates. An intravascular blood pump comprising: 23. The method according to claim 22, wherein the inner sheath or the outer sheath is attached to one of the sheaths and is adapted to engage the other sheath to lock the pump mechanism in the open state. An intravascular blood pump according to claim 1. 24. The intravascular blood pump according to claim 22, wherein the inner sleeve further comprises a support member, and the inner sheath is attached to the support member. 25. The inner sheath is attached to the support member by a spindle, the spindle having an inner lumen, a flange, and a bearing, the bearing having at least one slot, Providing at least one fluid connection between the lumen and the slot, the impeller having a cap attached to the drive cable, the cap being near, but not connected to, the flange of the spindle. 25. The intravascular blood pump of claim 24, having a flange disposed on the blood pump. 26. A means for directing the fluid flow to the inner sheath such that the fluid flow passes through the slot to form a fluid layer between the cap and a bearing of the spindle. 26. The intravascular blood pump of claim 25, further comprising: 27. The intravascular blood pump of claim 22, further comprising an inflatable balloon mounted on said outer sheath proximate said pump mechanism, and means for inflating said balloon. . 28. A bearing having a flange, an inner lumen, and a bearing generally near the flange, an end, at least one slot extending substantially between the flange and the end, and A sheath having a bearing with at least one channel along the end of the bearing for providing fluid communication between an inner lumen and the slot; and a drive cable partially enclosed by the inner lumen of the sheath. And an impeller provided in the drive cable so as to rotate when the drive cable rotates, the impeller receiving a bearing portion of the sheath, and a fluid from the fluid layer between the bearing and the bearing portion. To form a gap to purge blood,
An impeller having a cap provided near the flange of the sheath but arranged so as not to be connected, wherein the flow of fluid forms a fluid layer between the cap and the bearing. Means for directing fluid flow into the lumen of the sheath so as to pass through a slot. 29. The slot having a plurality of substantially equally spaced apart and longitudinally extending slots along the bearing, wherein the channel comprises a fluid between the inner lumen and the plurality of slots. 29. The intravascular blood pump of claim 28, having a plurality of channels along the end of the bearing for providing transmission. 30. The pump according to claim 28, wherein the pump has a proximal suction port and a distal discharge port, and the force of the blood pumped by the impeller drives the cap toward the end of the bearing. Blood pump in the blood vessels. 31. A pump housing having a central axis and an inlet and an outlet defining upstream and downstream directions, via a suction port downstream of the inlet in the housing and having the central axis. An inlet flow rectifier for conditioning the blood entering the pump housing, downstream of the inlet flow rectifier in the housing and provided for rotation to pump blood from the inlet to the outlet. And a wing downstream of the impeller in the housing and extending from near the impeller to near the outlet, the wing having a circumference of blood before the blood exits the outlet. Blood in the blood vessel having a discharge flow rectifier curved from a relatively radial orientation with respect to the central axis to a relatively axial direction with respect to the central axis so as to reduce the velocity configuration to the central axis. Blood pump in tube. 32. The pump housing is typically cylindrical and the outlet typically extends around the periphery of the pump housing, the pump housing typically promoting radially outward flow of blood through the outlet. 32. The blood pump according to claim 31, wherein the blood pump is provided near a discharge opening that is open to form a conical or truncated conical structure. 33. The blood pump according to claim 32, wherein the suction port has a plurality of suction ports radially spaced along the pump housing. 34. A drive cable operatively connected to said impeller for rotating said impeller, said rectifier for said suction flow extending such that said drive cable is operatively connected to said impeller. 34. The blood pump according to claim 33, having a passage therethrough.